Pharma Nobis, LLC
Form 483 issued March 13, 2020 · Texarkana, Texas
- Inspection
- Feb 24 – Mar 13, 2020
- Investigators
- Michelle A. Krayer· Shanna N. Purdy
- Observations
- 7
- Pages
- 9
- FEI number
- 1611206
In short: On March 13, 2020, FDA issued a Form 483 with 7 observations to Pharma Nobis, LLC in Texarkana, Texas (FEI 1611206) after an inspection that ran Feb 24 – Mar 13, 2020. The investigators were Michelle A. Krayer and Shanna N. Purdy. Most observations concern production and laboratory controls.
At a glance
Observations span 4 systems, led by production.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There is a failure to thoroughly review any unexplained discrepancy or the failure of a batch…
- 02
There are no written procedures for production and process controls designed to assure that the drug…
- 03
There is no written testing program designed to assess the stability…
- 04
Laboratory records are deficient in that they do not include a complete record of all…
This inspection in context
Michelle A. Krayer
11 documents · 2019–2024
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in Texas.
The firmPharma Nobis, LLC history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Pharma Nobis, LLC?
FDA listed 7 observations on this Form 483, mostly about production, laboratory controls and quality system. The opening words of each observation are shown on this page.
Who inspected Pharma Nobis, LLC?
Michelle A. Krayer and Shanna N. Purdy are named on this Form 483, for the inspection of Feb 24 – Mar 13, 2020. Each investigator has a profile showing what they cite most.
When was Pharma Nobis, LLC inspected by FDA?
The inspection ran Feb 24 – Mar 13, 2020, and the Form 483 is dated March 13, 2020.
How do I get the full Form 483 for Pharma Nobis, LLC?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.